泰国医疗器材登记法规问题集

泰国永辉BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰国籍说中文
Pay Xiao 泰国籍说英文

或
联络人：苏 玉 燕  副总经理
手机：+886-928-486-835
电话：+886-2-2717-0515 分机:104
或
Email：bkk4ww@evershinecpa.com

各国医疗器材登记法规问答集

HLF-TH-10
请问泰国对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of medical devices in Thailand?
What is its official name? What is the intensity of management of different categories?
What is the governmental authority of medical devices? Website?

Evershine RD：

医疗器材监管司隶属于食品药品监督管理局，负责控制和监督医疗器材。
医疗器材是指：
1.用于插入人体的工具、器具、机器、物体；用于实验室内外测试的试剂、产品、软件或任何专门用于人类或动物的其他产品。
无论製造商/所有者是单独使用还是与其他任何东西结合使用，如下：
．诊断、预防、监测、治疗、减轻或治癒疾病。
．诊断、监测、治疗、减轻或治疗伤害。
．检查、替换、纠正、修改、或支持身体的解剖、生理过程
．支持或挽救生命。
．避孕或辅助生殖。
．协助或协助补偿残疾。
．用于医疗或诊断尸体标本为目的之检查工具。
．销毁或消毒医疗器材。
2.与第1项的一起使用的医疗器材。
3.部长指定为医疗器材的工具、器具、机器、产品或其他物品。

医疗器材分为以下 2 组：

1.用于体外诊断的医疗器材
．第一类：对人体和公共卫生具有低风险。
．第二类：对人体和公共卫生具有中等风险。
．第三类：对人体构成高风险或对公共卫生有中等风险。
．第四类：对人和公共卫生构成高风险。

2.非体外诊断的医疗器材
．第一类：风险较低的医疗器材。
．第二类：具有中等风险的低等级医疗器材。
．第三类：具有中等风险的高水平医疗器材。
．第四类：高风险医疗器材。

3.规范：
．第一类低风险医疗器材、兽用医疗器材的製造商或进口商需要预先通知。
．第二、三类中等风险医疗器材的製造商或进口商需要预先做详细通知。
．第四类高风险医疗器材的製造商或进口商需要获得许可。

4.分组：
医疗器材分组是将外观相似的医疗器材放在一起并在申请中註册。
它减少了工作量、成本，并有利于文件的准备。 可分为以下6类：
．单品
．系统
．家族
．套装
．诊断试剂盒
．体外诊断产品

The Department of Medical Device Supervision is subordinate to the Food and Drug Administration and is responsible for controlling and supervising the operation of medical devices.
Other activities related to medical devices must contact the Food and Drug Administration and comply with regulations.

Medical equipment means:

1.Tools, utensils, machines, objects for insertion into the human body; reagents, products, software or any other product intended for use in humans or animals for testing inside or outside the laboratory.
Whether the manufacturer/owner is using it alone or in combination with anything else, as follows:
． Diagnose, prevent, monitor, treat, alleviate or cure disease.
． Diagnose, monitor, treat, mitigate or treat injury.
． Inspect, replace, correct, modify, or support anatomical, physiological processes of the body
． Support or save lives.
． Contraception or assisted reproduction.

． Assist or assist in compensating for disability.

．  Examination tools used for medical or diagnostic purposes of cadaveric specimens.

． Destroy or sterilize medical equipment.

2.Accessories for use with the medical device of item 1.

3.Tools, appliances, machines, products or other items designated by the Minister as medical devices.

Medical devices are divided into 2 groups:

1.Medical devices used for in vitro diagnosis

． Class 1: Low risk to humans and public health.

． Class II: Moderate risk to humans and public health.

． Class III: High risk to humans or moderate risk to public health.

． Class IV: High risk to human and public health.

2.Non-in vitro diagnostic medical devices

． Class 1: Low-risk medical devices.

． Class II: Low-grade medical devices with moderate risk.

． Class III: High-level medical devices with moderate risk.

． Class IV: High-risk medical devices.

3.Specifications:

． Manufacturers or importers of Class I low-risk medical devices, veterinary medical devices, require advance notice.

． Manufacturers or importers of Class II and III medium-risk medical devices need to give detailed notice in advance.

． Manufacturers or importers of Class IV high-risk medical devices need to be licensed.

4.Grouping:
Grouping of medical devices is the grouping of similar-looking medical devices together and registered in the application. It reduces effort, cost, and facilitates document preparation. It can be divided into 6 categories:
．Single
．System
．Family
．Set
．IVD Test Kit
．IVD Cluster

【参考连结】

URL:https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

https://www.fda.moph.go.th/sites/Medical/Pages/Main.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

HLF-TH-20
外国公司要到泰国销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell medical devices in Thailand, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

欲製造或进口医疗器材者必须註册企业登记，申请註册需符合以下规定：

1. 是申请设立登记证的企业主。
2. 年龄不低于二十岁。
3. 在泰国有住所。
4. 不是破产者。
5. 从未因法律规定的失信行被终审判决判处有期徒刑；或违反本法的罪行，除非在登记之日前已通过处罚两年以上。
6. 不是精神不健全者。
7. 没有法律规定的疾病。
8. 製造或进口的医疗器材之生产、控制、保存符合法律中规定的品质。
9. 未与被吊销或登记证一年内未补办的商业名称、登记人相同或者近似。
10. 非依本法被吊销登记证者。
11. 从未依本法被吊销登记证，除非在申请设立登记之日起撤销满两年以上。

依据规定提出申请且被许可的製造商或进口商，被视为销售者，无需另外提交销售许可申请。

Anyone wishing to manufacture or import medical devices must register with a business registration, and the application for registration must comply with legal rules, procedures and conditions:

1. Be the business owner applying for the establishment registration certificate.
2. Not less than twenty years old.
3. Domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts stipulated by law; or a crime against this law, unless the punishment has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no legally defined diseases.
8. The production, control and preservation of medical devices manufactured or imported conform to the quality stipulated in the law.
9. Not the same or similar to the business name or registrant whose registration certificate has not been reissued within one year.
10. Those whose registration certificate has been revoked not in accordance with this Act.
11. The registration certificate has never been revoked in accordance with this act, unless it has been revoked for more than two years from the date of application for establishment registration.

Manufacturers or importers who apply and are licensed in accordance with the regulations are considered sellers and do not need to submit a separate application for sales authorization.

【参考连结】

https://www.dbd.go.th/dbdweb_en/index.php#

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

HLF-TH-30
外国公司要到泰国销售医疗器材，可以指派泰国公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？
外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell medical devices in Thailand, can it assign a Thailand company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

欲销售医疗器材者应申请销售许可证，在获得许可证后，可以依照法律规定的规则销售该医疗器材。
依据规定提出申请企业登记且被许可的製造商或进口商，被视为销售者，则无需另外提交销售许可申请。

申请医疗器材销售许可证条件：

1. 企业者
2. 年龄不低于二十岁。
3. 在泰国有住所。
4. 不是破产者。
5. 从未因法律规定的失信行被终审判决判处有期徒刑；或违反本法的罪行，除非在登记之日前已通过处罚两年以上。
6. 不是精神不健全者。
7. 没有法律规定的疾病。
8. 不得使用与处于暂停营业登记证或者暂停营业期间的营业所登记人或被许可人的业务名称相同或者近似的商业名称
9. 不是根据本法被吊销执照的人
10. 从未根据本法被吊销执照，除非许可证在提交申请之日前被吊销两年以上
11. 具有规定的销售质量体系
12. 有符合规定的销售主管
13. 法人申请许可时，经营业务的法人经理或代表必须具备上述资格。

机构註册人、领有许可证者的责任：

1. 控制和监督医疗器材生产、进口或者销售业务符合规定的质量。
2. 安排人员监督医疗器材的製造、进口或销售，并监督该人员完全履行职责。
3. 製作、进口或者销售医疗器材的报告供主管检查并根据规定向主管机关许可人提交报告。
4. 製作医疗器材异常性能报告，或与消费者发生的不良事件，并向主管机关报告该医疗器材使用安全的改正措施，无论其在国内外是否出现异常性能或发生此类事件，均需要按照主管机关公佈的规则、程序和条件执行。
5. 提供投诉渠道，製作製造、进口或销售有关的投诉管理系统、投诉记录且根据部长订定的规则、程序和条件以供主管机关检查。
6. 提供医疗器材产地标誌、进口地、销售地或储存地在显眼处。视主管机关规定的规则、程序和条件设立登记证、执照。
7. 生产地、进口地、销售地点的显眼地方须标示医疗器材控制者的姓名和资格。
8. 在显眼的地方展示登记证、医疗器材销售许可证于规定位置上。
9. 提供医疗器材质量、标准、功效和安全性的技术文件供检验。

Anyone wishing to sell medical devices should apply for a license, and after obtaining the license, the medical equipment can be sold in accordance with the rules prescribed by law.
Manufacturers or importers who apply and are licensed of business registration in accordance with the regulations are considered sellers and do not need to submit a separate application for sales authorization.

Conditions for applying for a medical device sales license:

1. Entrepreneur
2. Not less than twenty years old.
3. Have a domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts prescribed by law; or a crime against this law, unless the penalty has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no diseases prescribed by law.
8. Not to use a business name that is the same as or similar to the business name of the registrant or licensee of the establishment that is in the period of suspension of business registration or suspension of business
9. Not a person whose license has been revoked under this Act
10. Has never had a license revoked under this Act unless the license was revoked more than two years prior to the date of filing the application
11. Have a prescribed sales quality system
12. Have a qualified sales executive
13. When a legal person applies for a license, the manager or representative of the legal person operating the business must have the above qualifications.

Responsibilities of Institutional Registrants and Licensees:

1. Control and supervise the quality of medical equipment production, import or sales.
2. Assign a person to supervise the manufacture, import or sale of medical equipment and supervise that person to perform their duties fully.
3. The report on the production, import or sale of medical equipment is to be inspected by the competent authority and the report shall be submitted to the competent authority licensor according to regulations.
4. Make a report on abnormal performance of medical devices or adverse events with consumers, and report to the competent authority the corrective measures for the safety of the use of the medical device, regardless of whether abnormal performance or such events occur at home and abroad The rules, procedures and conditions published by the competent authority are enforced.
5. To provide channels for complaints, to make a complaint management system related to manufacture, import or sale, record complaints and make them available for inspection by the competent authorities in accordance with the rules, procedures and conditions established by the Minister.
6. Provide the medical device’s place of origin, import, sale or storage in a conspicuous place. Registration certificates and licenses are established in accordance with the rules, procedures and conditions prescribed by the competent authority.
7. The name and qualifications of the controller of the medical device must be marked in a conspicuous place at the place of production, import and sale.
8. Display the registration certificate and medical equipment sales license in a conspicuous place in the specified position.
9. Provide technical documentation of medical device quality, standard, efficacy and safety for inspection.

【参考连结】

https://privus.fda.moph.go.th/index.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

HLF-TH-40
外国公司销售到泰国医疗器材本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文除了泰文外，其他哪种语文也可以？网页？

Do foreign companies need to apply for an approval before importing medical devices sold to Thailand?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

需要。依照医疗器材风险分类向食品药品监督管理局申请产品註册，获得销售授权：以电子方式提交申请直至完成许可程序，获得製造/进口医疗器材销售证书。

1.第一类低风险医疗器材、兽用医疗器材。

．製造/进口企业註册号

．经营委託书

．医疗器材名称、标籤、产品规格文件

．外国註册的历史文件

．生产或进口医疗器材的无菌试验证明文件

．生产或进口医疗器材用于测量、测试或校准的文件

．製造商或产品所有人出具的产品合格证书

．产品所有人代理进口申请的委託书

2.第二、三类中等风险医疗器材

．製造/进口企业註册号

．经营委託书

．医疗器材名称、标籤、产品规格、製造内容及产品所有者等详细文件

．医疗器材安全和性能的文件

．总结设计验证和确认的文件

．风险分析的文件

．使用后产生的废弃物其销毁、变质或者消除方法的文件

．质量证书

．製造商或产品所有者製造方式、使用目的、说明、包装、标籤

．製造商或产品所有人出具的产品合格证书

．分销製造商或产品所有者的销售历史证明

．产品製造商或所有者证明安全的证书

．国外食品药品监督管理局许可的证明

．代理进口申请的委託书

3.第四类高风险医疗器材

．製造/进口企业註册号

．经营委託书

．医疗器材名称、标籤、产品规格、製造内容及产品所有者等详细文件

．医疗器材安全和性能的文件

．总结设计验证和确认的文件

．风险分析的文件

．使用后产生的废弃物其销毁、变质或者消除方法的文件

．质量证书

．製造商或产品所有者製造方式、使用目的、说明、包装、标籤

．製造商或产品所有人出具的产品合格证书

．分销製造商或产品所有者的销售历史证明

．产品製造商或所有者证明安全的证书

．国外食品药品监督管理局许可的证明

．代理进口申请的委託书

医疗器材标籤规范：

1. 需要贴上国外和国内製造商的标籤、和符合公共卫生部通知的标籤
2. 包装盒标籤(贴在产品盒上的标籤)：需标示型号名称

．家庭使用：根据法律规定的主题以泰语编写。

．专业用途：根据法律规定的主题以英语或泰语编写。

3. 医疗器材详细资讯需取自製造商的标籤、用户手册。
4. 医疗设备文件是显示产品详细讯息（例如设备特性）。
5. 产品包装​​盒内应包含医疗用途、使用适应症、使用说明、警告、注意事项等说明。

Apply for product registration to the Food and Drug Administration in accordance with the medical device risk classification and obtain sales authorization: submit the application electronically until the licensing process is completed, and obtain a manufacturing/imported medical device sales certificate.

1. Class I low-risk medical equipment and veterinary medical equipment.

． Manufacturing/importing company registration number

． Business Power of Attorney

． Medical device name, label, product specification file

． Foreign registered historical documents

． Proof of sterility test for production or import of medical devices

． Documentation of the manufacture or import of medical devices for measurement, testing or calibration

． Product conformity certificate issued by the manufacturer or product owner

． Power of Attorney for the product owner to act as an agent for import application

2. Class II and III medium-risk medical devices

． Manufacturing/importing company registration number

． Business Power of Attorney

． Details of medical device name, label, product specification, manufacturing content and product owner

． Documents for Medical Device Safety and Performance

． Document summarizing design verification and validation

． Documents for Risk Analysis

． Documents on the method of destruction, deterioration or elimination of waste generated after use

． quality certificates

． How the manufacturer or product owner made it, purpose of use, directions, packaging, labeling

． Product Certificate of Conformity issued by the manufacturer or product owner

． Proof of sales history from distributor manufacturer or product owner

． Product manufacturer or owner certificate certifying safety

． Certificate of approval from foreign food and drug administrations

． Power of Attorney for Import Application

3. Class IV high-risk medical devices

． Manufacturing/importing company registration number

． Business Power of Attorney

． Detailed documents such as medical device name, label, product specification, manufacturing content and product owner

． Documentation of Medical Device Safety and Performance

． Document summarizing design verification and validation

． Risk Analysis Documents

． Documents on the method of destruction, deterioration or elimination of waste generated after use

． quality certificates

． How the manufacturer or product owner made it, purpose of use, instructions, packaging, labelling

． Product conformity certificate issued by the manufacturer or product owner

． Proof of sales history from the distributor manufacturer or product owner

． Product manufacturer or owner certificate certifying safety

． Certificate of Foreign Food and Drug Administration License

． Power of Attorney for Import Application

Device Labeling specification:

1. Labeling of foreign and domestic manufacturers, and labels in compliance with Ministry of Public Health notices
2. Box label (label attached to the product box): need to indicate the model name

． For Home Use: Written in Thai according to the subject matter required by law.

． Professional Use: Written in English or Thai depending on the subject matter required by law.

3. The detailed information of the medical device should be taken from the manufacturer’s label, user manual.
4. The medical device file is to display product details (eg device characteristics).
5. The product packaging box should contain instructions for medical use, indications for use, instructions for use, warnings, precautions, etc.

【参考连结】

https://www.fda.moph.go.th/sites/Medical/SitePages/overview_MDC_product_registration.aspx

http://www.krisdika.go.th/librarian/get?sysid=773817&ext=htm

https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

HLF-TH-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了泰文外，其他哪种语文也可以？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

须以泰国当地公司名义申请。
欲製造或进口医疗器材者必须註册企业登记，申请註册需符合以下规定：

1. 是申请设立登记证的企业主。
2. 年龄不低于二十岁。
3. 在泰国有住所。
4. 不是破产者。
5. 从未因法律规定的失信行被终审判决判处有期徒刑；或违反本法的罪行，除非在登记之日前已通过处罚两年以上。
6. 不是精神不健全者。
7. 没有法律规定的疾病。
8. 製造或进口的医疗器材之生产、控制、保存符合法律中规定的品质。
9. 未与被吊销或登记证一年内未补办的商业名称、登记人相同或者近似。
10. 非依本法被吊销登记证者。
11. 从未依本法被吊销登记证，除非在申请设立登记之日起撤销满两年以上。

医疗器材标籤规范：

1. 需要贴上国外和国内製造商的标籤、和符合公共卫生部通知的标籤
2. 包装盒标籤(贴在产品盒上的标籤)：需标示型号名称

．家庭使用：根据法律规定的主题以泰语编写。

．专业用途：根据法律规定的主题以英语或泰语编写。

3. 医疗器材详细资讯需取自製造商的标籤、用户手册。
4. 医疗设备文件是显示产品详细讯息（例如设备特性）。
5. 产品包装​​盒内应包含医疗用途、使用适应症、使用说明、警告、注意事项等说明。

Anyone wishing to manufacture or import medical devices must register with a business registration, and the application for registration must comply with legal rules, procedures and conditions:

1. Be the business owner applying for the establishment registration certificate.
2. Not less than twenty years old.
3. Domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts stipulated by law; or a crime against this law, unless the punishment has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no legally defined diseases.
8. The production, control and preservation of medical devices manufactured or imported conform to the quality stipulated in the law.
9. Not the same or similar to the business name or registrant whose registration certificate has not been reissued within one year.
10. Those whose registration certificate has been revoked not in accordance with this Act.
11. The registration certificate has never been revoked in accordance with this act, unless it has been revoked for more than two years from the date of application for establishment registration.

Device Labeling specification:

1. Labeling of foreign and domestic manufacturers, and labels in compliance with Ministry of Public Health notices
2. Box label (label attached to the product box): need to indicate the model name

． For Home Use: Written in Thai according to the subject matter required by law.

． Professional Use: Written in English or Thai depending on the subject matter required by law.

3. The detailed information of the medical device should be taken from the manufacturer’s label, user manual.
4. The medical device file is to display product details (eg device characteristics).
5. The product packaging box should contain instructions for medical use, indications for use, instructions for use, warnings, precautions, etc.

【参考连结】

https://www.dbd.go.th/dbdweb_en/index.php#

https://www.fda.moph.go.th/sites/Medical/SitePages/overview_MDC_product_registration.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

HLF-TH-60
经过核准登记的医疗器材，进口到泰国要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved medical devices into Thailand?
What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

欲销售医疗器材者应申请销售许可证，在获得许可证后，可以依照法律规定的规则销售该医疗器材。依据规定提出申请企业登记且被许可的製造商或进口商，被视为销售者，则无需另外提交销售许可申请。

申请医疗器材销售许可证条件：

1. 企业者
2. 年龄不低于二十岁。
3. 在泰国有住所。
4. 不是破产者。
5. 从未因法律规定的失信行被终审判决判处有期徒刑；或违反本法的罪行，除非在登记之日前已通过处罚两年以上。
6. 不是精神不健全者。
7. 没有法律规定的疾病。
8. 不得使用与处于暂停营业登记证或者暂停营业期间的营业所登记人或被许可人的业务名称相同或者近似的商业名称9. 不是根据本法被吊销执照的人
9. 从未根据本法被吊销执照，除非许可证在提交申请之日前被吊销两年以上
10. 具有规定的销售质量体系
11. 有符合规定的销售主管
12. 法人申请许可时，经营业务的法人经理或代表必须具备上述资格。

医疗器材实体销售业者註册提供资料：

1. 承诺书
2. 请求销售同意书(经销商)
3. 委託书(製造商或进口商)
4. 医疗器材销售授权书
5. 地图(详细描述医疗器材销售、仓储地点的路程)
6. 销售及仓储照片

．远观照片
．招牌
．地址
．医疗器材销售的橙色标誌(尺寸不小于 20×70 厘米，并以白色泰文显示不少于 3 厘米)
．医疗器材存放场所标誌的红色标誌(尺寸不小于 20×70 厘米，并以白色泰文显示不少于 3 厘米)
．往医疗器材销售处的照片
．医疗器材销售办公室开业照片
．医疗器材销售办公区域内的照片
．通向医疗器材存放区的照片
．存放医疗设备的区域的标誌照片
．医疗器材储藏室内的照片有一个存放工具的装置(例如：货架、托盘或冰箱等，并带有指示牌)
．如果建筑物楼层有很多，必须在每张图片中表示所述用作销售和储存医疗器材的办公室在哪一层
．可以用多张图片来描述
．可以给额外的图像将描述更清楚

7. 销售医疗器材标誌的申请书
8. 医疗器材储存设施的同意书

机构註册人、领有许可证者的责任：

1. 控制和监督医疗器材生产、进口或者销售业务符合规定的质量。
2. 安排人员监督医疗器材的製造、进口或销售，并监督该人员完全履行职责。
3. 製作、进口或者销售医疗器材的报告供主管检查并根据规定向主管机关许可人提交报告。
4. 製作医疗器材异常性能报告，或与消费者发生的不良事件，并向主管机关报告该医疗器材使用安全的改正措施，无论其在国内外是否出现异常性能或发生此类事件，均需要按照主管机关公佈的规则、程序和条件执行。
5. 提供投诉渠道，製作製造、进口或销售有关的投诉管理系统、投诉记录且根据部长订定的规则、程序和条件以供主管机关检查。
6. 提供医疗器材产地标誌、进口地、销售地或储存地在显眼处。视主管机关规定的规则、程序和条件设立登记证、执照。
7. 生产地、进口地、销售地点的显眼地方须标示医疗器材控制者的姓名和资格。
8. 在显眼的地方展示登记证、医疗器材销售许可证于规定位置上。
9. 提供医疗器材质量、标准、功效和安全性的技术文件供检验。

Anyone wishing to sell medical devices should apply for a license, and after obtaining the license, the medical equipment can be sold in accordance with the rules prescribed by law.
Manufacturers or importers who apply and are licensed of business registration in accordance with the regulations are considered sellers and do not need to submit a separate application for sales authorization.

Conditions for applying for a medical device sales license:

1. Entrepreneur
2. Not less than twenty years old.
3. Have a domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts prescribed by law; or a crime against this law, unless the penalty has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no diseases prescribed by law.
8. Not to use a business name that is the same as or similar to the business name of the registrant or licensee of the establishment that is in the period of suspension of business registration or suspension of business 9. Not a person whose license has been revoked under this Act
9. Has never had a license revoked under this Act unless the license was revoked more than two years prior to the date of filing the application
10. Have a prescribed sales quality system
11. Have a qualified sales executive
12. When a legal person applies for a license, the manager or representative of the legal person operating the business must have the above qualifications.

Information provided for registration of medical device sales enterprises:

1. Commitment
2. Request for Sales Consent (Dealer)
3. Power of Attorney (Manufacturer or Importer)
4. Medical Device Sales Authorization
5. Map (describe in detail the distance of medical device sales and storage locations)
6. Sales and Warehousing Photos

．Photos from a distance

．Shop sign

．Address

．Orange sign for sale of medical device (dimensions not less than 20×70 cm and not less than 3 cm displayed in white Thai)

．Red sign for medical device storage place sign (dimensions not less than 20×70 cm and not less than 3 cm displayed in white Thai)

．Photo to the medical device sales office

．Medical device  sales office opening photo

．Photo inside the medical device sales office area

．photo leading to the medical device  storage area

．Photo of a sign of an area where medical device is stored

．Photo of medical device  storage room with a device for storing tools (eg: shelf, tray, or refrigerator, etc., with signage)

．If there are many floors in the building, each picture must indicate which floor of the office used for the sale and storage of medical device is located

．Can be described with multiple pictures

．Can give additional images to describe more clearly

7. Application for Sale of Medical Device Mark
8. Consent for Medical Device Storage Facility

Responsibilities of Institutional Registrants and Licensees:

1. Control and supervise the quality of medical equipment production, import or sales.
2. Assign a person to supervise the manufacture, import or sale of medical equipment and supervise that person to perform their duties fully.
3. The report on the production, import or sale of medical equipment is to be inspected by the competent authority and the report shall be submitted to the competent authority licensor according to regulations.
4. Make a report on abnormal performance of medical devices or adverse events with consumers, and report to the competent authority the corrective measures for the safety of the use of the medical device, regardless of whether abnormal performance or such events occur at home and abroad The rules, procedures and conditions published by the competent authority are enforced.
5. To provide channels for complaints, to make a complaint management system related to manufacture, import or sale, record complaints and make them available for inspection by the competent authorities in accordance with the rules, procedures and conditions established by the Minister.
6. Provide the medical device’s place of origin, import, sale or storage in a conspicuous place. Registration certificates and licenses are established in accordance with the rules, procedures and conditions prescribed by the competent authority.
7. The name and qualifications of the controller of the medical device must be marked in a conspicuous place at the place of production, import and sale.
8. Display the registration certificate and medical equipment sales license in a conspicuous place in the specified position.
9. Provide technical documentation of medical device quality, standard, efficacy and safety for inspection.

【参考连结】

https://privus.fda.moph.go.th/index.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

HLF-TH-70
泰国医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

在泰国进行医疗器材註册需要获得良好作业规范认证或是等同其品质系统管理认证。
良好作业规范认证所需资料：

1. 医疗器材製造企业註册证
2. 认证医疗器材的内容

．医疗器材製造地址

．电话

．製造商

3. 认证医疗器材的范围(泰语、英语)
4. 申请认证范围内的员工人数、工作日、工作时间、换班次数
5. 被认证医疗器材的风险等级(1.2.3.4)
6. 各种质量体系认证(例如：国外GMP认证、ISO认证)
7. 机构内流程(全线生产+设计与开发/全线生产但不包括设计和开发/重新包装)
8. 质量体系相关内容

．联繫人（应代表管理层或了解组织质量体系的人）

．姓名、职位、电话、手机、电子邮件、地址

9. 承诺书：遵守依循医疗器材管制司的规定和条件设置、被设置或修改，以及缴交相关认证审核费用。

10 同意书：同意医疗器材管理部门的官员或企业审查单位随时检查。

11. 附上供审议的证据和文件如下：

．製造企业註册证影本

．法人登记证

．医疗器材或质量体系的认可（如果有）

．医疗器材生产企业位置图和内部图1份

．医疗器材和部门关係

．製造过程简图及获得认证的医疗器械材产品2套

．质量手册

．操作规则标准或手册1套

．监测和控制影响产品质量的环境因素

．生产和运营服务

．服务、测量程序和使用的材料

．确认过程的验证

．产品标识及产品检验情况

．可追溯性

．产品存储

．检测仪器控制

．内部审核

．不合格品的控制

Registration of medical devices in Thailand requires certification of Good Manufacturing Practice or its equivalent in Quality System Management.
Documents required for Good Practice Certification:

1. Medical Device Manufacturing Enterprise Registration Certificate
2. Contents of certified medical devices

． Medical device manufacturing address

． Telephone

． manufacturer

3. Scope of certified medical devices (Thai, English)
4. The number of employees, working days, working hours, and shift times within the scope of the certification application
5. Risk level of certified medical devices (1.2.3.4)
6. Various quality system certifications (for example: foreign GMP certification, ISO certification)
7. In-house processes (full production + design and development/full production but excluding design and development/repackaging)
8. Contents related to quality system

． Contact (should represent management or someone with knowledge of the organization’s quality system)

． Name, title, phone, mobile, email, address

9. Commitment: To comply with the regulations and conditions of the Medical Device Control Department to set, be set or modified, and pay the relevant certification and audit fees.

10 Consent letter: Agree to inspect at any time by officials of the medical device management department or the enterprise review unit.

11. The evidence and documents attached for consideration are as follows:

． Manufacturing enterprise registration certificate copy

． Legal person registration certificate

． Approval of medical device or quality system (if any)

． 1 copy of the location map and internal map of the medical equipment manufacturer

． Medical Devices and Department Relations

． Manufacturing process diagram and 2 sets of certified medical device products

． Quality Manual

． 1 set of operating rules standard or manual

． Monitoring and Controlling Environmental Factors Affecting Product Quality

． Production and Operational Services

． Services, Measurement Procedures and Materials Used

． Validation of confirmation process

． Product identification and product inspection

． traceability

． product storage

． Testing Instrument Control

． Internal review

． Control of non-conforming products

【参考连结】

https://privus.fda.moph.go.th/index.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/Relative.aspx

HLF-TH-75
泰国医疗器材审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

HLF-TH-80
外国子公司进口医疗器材后，如果委託泰国的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？
是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports medical devices and entrusts a distributor in Thailand to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

为了保护消费者的健康和安全，当怀疑任何医疗设备质量不佳或使用上可能对健康有害时，秘书长有权责令医疗器材製造商或进口商提交证明其质量的文件或证据。
诉讼期间秘书长有权暂停生产、进口或销售，直至证明该医疗器材质量良好，符合标准的安全性能。
当已获知任何医疗器材的质量、标准或功效不符合许可或使用不安全可能对健康有害时，秘书长具有下列权力：

1. 以书面形式向领有许可证者发出命令，令其修正。
2. 以书面形式向製造商、进口商、销售商或持有医疗器材使用的人发出命令，令其改进製造、进口、销售或拥有的医疗器材。
3. 书面责令医疗器材生产企业、进口企业或者销售企业停止生产、进口或者销售医疗器材，或採取规定的其他相关行动。
4. 公佈医疗器材检验或者分析结果，并将任何违反或不遵守的行为公告社会。
5. 向生产者、进口者、销售者或者持有人收取医疗器材，或者责令期限内将其生产、进口或者从市场上售回的医疗器材召回。

医疗器材的製造商、进口商或销售商应对使用医疗器材造成的任何损害负责，除非能够证明损坏是由于不可抗力造成的，或不是因为医疗器材的瑕疵引起的，或者因为受害人本身的过错造成。
上述的损害索赔包含身体或健康受到损害而造成的精神损害，自伤者知悉损害并知道谁应承担损害赔偿责任之日起有三年追索权。

In order to protect the health and safety of consumers, the Secretary-General has the power to order the manufacturer or importer of medical devices to submit documents or evidence to prove its quality when it is suspected that any medical devices is of poor quality/performance may be harmful to health.
During the proceedings, the Secretary-General has the right to suspend the production, import or sale of the medical device until it is proved that the medical device is good quality, safe and standard in performance.

The Secretary-General has the powers to:

1. Issue a written order to the licensed person to amend.
2. Issue a written order to the manufacturer, importer, seller, or person in possession of the medical device to improve the medical device that it manufactures, imports, sells, or possesses.
3. Order in writing the medical equipment manufacturer, importer or sales enterprise to stop the production, import or sale of medical equipment, or to take other relevant actions as specified.
4. Publish the results of medical equipment inspection or analysis, and announce any violation or non-compliance to the public.
5. Collect medical equipment from producers, importers, sellers or holders, or order the recall of medical equipment produced, imported or sold from the market within the time limit.

The manufacturer, importer or seller of a medical device is liable for any damage caused by the use of the medical device, unless it can be shown that the damage was caused by force majeure, or was not caused by a defect in the medical device, or was caused by the victim’s own fault. For the damage claims mentioned above, including mental damage caused by damage to body or health, the self-injured person has a three-year recourse period after knowing the damage and knowing who should be liable for the damage.

【参考连结】

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

各国医疗器材登记法规问答集

泰国永辉BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰国籍说中文
Pay Xiao 泰国籍说英文

或
联络人：苏 玉 燕  副总经理
手机：+886-928-486-835
电话：+886-2-2717-0515 分机:104
或
Email：bkk4ww@evershinecpa.com

永辉关係企业: 泰国永辉服务有限公司
Evershine Services (Thailand) Co., Ltd
https://bkk.evershinecpa.com
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
Bangkok Manager Paul Xiao, who speaks in both English and Thai.
M: +66-(0)852-222-197

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永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

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